Last updated: 01/27/2020 10:10:03
Meta-analysis of risk of intussusception after the first and the second dose of Rotarix and Rotateq
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Meta-analysis of risk of intussusception after the first and the second dose of Rotarix and Rotateq
Trial description: The aim of this planned analyses linked to Post-Authorization Safety Study (PASS) is to assess the risk of Intussusception after the 1st and the 2nd dose of Rotarix and Rotateq vaccines and provide an overall estimate of the risk after each dose by combining results from different studies using meta-analysis method.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Relative risk of Intussusception (IS) following the 1st and the 2nd dose of Rotarix and Rotateq vaccines
Timeframe: During the 7 days (Day 0 - Day 6) after vaccination
Secondary outcomes:
Not applicable
Interventions:
Other: Data collection
Enrollment:
1
Observational study model:
Other
Primary completion date:
2013-19-06
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
June 2013 to June 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
6 Weeks - 1 Year
Accepts healthy volunteers
none
- Subjects (> 6 weeks of age) vaccinated with Rotarix and Rotateq vaccines who participated in studies that met the following criteria:
- Post-marketing studies (no clinical trials);
- Not Applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Post-marketing studies (no clinical trials);
- Risk estimated for the 7-day period after vaccination;
- Risk estimated for dose 1 and dose 2, separately;
- Data obtained through active and/or passive surveillance on “confirmed” IS cases (Brighton or other method of case adjudication);
- Full report or publication available.
Subjects (> 6 weeks of age) vaccinated with Rotarix and Rotateq vaccines who participated in studies that met the following criteria:
Exclusion criteria:
Not Applicable
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Protocol and statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2013-19-06
Actual study completion date
2013-19-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
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Additional information
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